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Pre-emptive Trans-cutaneous Versus Trans-oral Ultrasound Guided Peritonsillar Infiltration With Bupivacaine During Tonsillectomy

A

Assiut University

Status

Unknown

Conditions

Postoperative Pain Management

Treatments

Other: trans-cutaneous ultrasound guided peritonsillar infiltration
Other: trans-oral ultrasound guided peritonsillar infiltration

Study type

Interventional

Funder types

Other

Identifiers

NCT03361813
201617019.2P

Details and patient eligibility

About

Ultrasound as a technique is safe, readily available, quick and portable allowing more accuracy of different regional blocks and local infiltration. It allows imaging of the mouth, oropharynx, infrahyoid structures, larynx, vocal cords, and trachea. Recently, ultrasound has been shown to improve accuracy in ultrasound guided block with local anesthetic infiltration. The objective of our study is to compare the effect of pre-emptive trans-oral ultrasound guided peritonsillar infiltration versus trans-cutaneous ultrasound (US) guided peritonsillar infiltration with bupivacaine for post-tonsillectomy analgesia, on surgical field, and surgeon satisfaction(intra-operative reactionary bleeding).

Materials and Methods: the patients will be admitted for tonsillectomy at ENT department of the Al- Azhar university hospitals. The patients' ages between 3 to 15 years. Patients will be divided into Cutaneous group: patients will be submitted to Trans-cutaneous ultrasound guided peritonsillar infiltration with bupivacaine, and Oral group: patients will be submitted to Trans-oral ultrasound guided peritonsillar infiltration with bupivacaine.

Enrollment

60 estimated patients

Sex

All

Ages

3 to 15 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ASA (American Society of Anesthesiologists) physical status I-II with no airway complications or systemic diseases or known psychological diseases. Reason for their surgery was recurrent or chronic tonsillitis.

Exclusion criteria

  • Infection at the site of injection, peritonsillar abscess or cellulites.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups, including a placebo group

trans-cutaneous ultrasound guided peritonsillar infiltration
Active Comparator group
Treatment:
Other: trans-oral ultrasound guided peritonsillar infiltration
trans-oral ultrasound guided peritonsillar infiltration
Placebo Comparator group
Treatment:
Other: trans-cutaneous ultrasound guided peritonsillar infiltration

Trial contacts and locations

1

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Central trial contact

Warda D K Ali, MD

Data sourced from clinicaltrials.gov

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